Rinvoq is a medicine that acts on the immune system (the body’s natural defences) and is used to treat:
- adults with moderate to severe rheumatoid arthritis (a disease that causes inflammation of the joints) that cannot be controlled well enough with disease-modifying anti-rheumatic medicines (DMARDs) or if the patient cannot take these medicines. It can be used on its own or with methotrexate, another medicine that acts on the immune system;
- adults with active psoriatic arthritis (inflammation of the joints associated with psoriasis, a disease causing red, scaly patches on the skin) that cannot be controlled well enough with DMARDs, or if the patient cannot take these medicines. Rinvoq can be used on its own or with methotrexate;
- adults with active axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis, when X-ray shows the disease, and non-radiographic axial spondyloarthritis, when there are clear signs of inflammation but X-ray does not show disease. It is used when other treatments do not work well enough;
- adults and children from 12 years of age with moderate to severe atopic dermatitis (also known as eczema, when the skin is itchy, red and dry) who can be treated with a medicine given by mouth or by injection;
- adults with ulcerative colitis (a disease that causes inflammation and ulcers in the lining of the bowel). Rinvoq is used to treat moderately to severely active ulcerative colitis when other medicines, including biological medicines, do not or no longer work, or if the patient cannot take them.
Rinvoq contains the active substance upadacitinib.
Rinvoq : EPAR - Medicine overview (PDF/150.93 KB)
First published: 18/12/2019
Last updated: 08/09/2022
Rinvoq : EPAR - Risk-management-plan summary (PDF/222.63 KB)
First published: 18/12/2019
Last updated: 23/08/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
AbbVie Deutschland GmbH & Co. KG
|Date of issue of marketing authorisation valid throughout the European Union||
27/07/2022 Rinvoq - EMEA/H/C/004760 - II/0016
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 202011/12/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 201918/10/2019